HepatAmine

HEPATAMINE- isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, histidine, proline, serine, glycine, cysteine hydrochloride and phosphoric acid injection, solution
B. Braun Medical Inc.

Protect from light until use.

DESCRIPTION

HepatAmine® (8% Amino Acid Injection) is a sterile, nonpyrogenic, hypertonic solution containing crystalline amino acids. A 500 mL unit provides a total of 40 g of amino acids and 6 g of nitrogen (38 g of protein equivalent).

Each 100 mL contains:

Essential Amino Acids

Isoleucine USP……………………………………….0.90 g

Leucine USP………………………………………….1.10 g

Lysine…………………………………………………..0.61 g

(added as Lysine Acetate USP………………..0.86 g)

Methionine USP……………………………………..0.10 g

Phenylalanine USP…………………………………..0.10 g

Threonine USP……………………………………….0.45 g

Tryptophan USP…………………………………..0.066 g

Valine USP……………………………………………0.84 g

Nonessential Amino Acids

Alanine USP…………………………………………..0.77 g

Arginine USP………………………………………….0.60 g

Histidine USP………………………………………….0.24 g

Proline USP……………………………………………0.80 g

Serine USP…………………………………………….0.50 g

Glycine USP…………………………………………..0.90 g

Cysteine…………………………………………….<0.014 g

(as Cysteine HCl•H2 O USP………………..<0.020 g)

Phosphoric Acid NF………………………………0.115 g

Sodium Bisulfite (as an antioxidant)…………….<0.1 g

Water for Injection USP………………………………..qs

pH adjusted with Glacial Acetic Acid USP

pH: 6.5 (6.0–6.8)

Calculated Osmolarity: 785 mOsmol/liter

Concentration of Electrolytes (mEq/liter): Sodium 10; Chloride <3

Phosphate (HPO=4 symbol) 20 (10 mmole P/liter); Acetate Approx. 62 (provided as acetic acid and Iysine acetate)

CLINICAL PHARMACOLOGY

HepatAmine® provides a mixture of essential and nonessential amino acids with high concentrations of the branched chain amino acids isoleucine, leucine, and valine, and low concentrations of methionine and the aromatic amino acids phenylalanine and tryptophan, relative to general purpose amino acid injections. This amino acid composition has been specifically formulated to provide a well tolerated nitrogen source for nutritional support and therapy of patients with liver disease who have hepatic encephalopathy.

The precise mechanisms which produce the therapeutic effects of HepatAmine® are not known. The etiopathology of hepatic encephalopathy is also unknown and is thought to be of multifactorial origin. The rationale for HepatAmine® is based on observations of plasma amino acid imbalances in patients with liver disease and on theories which postulate that these abnormal patterns are causally related to the development of hepatic encephalopathy.

Clinical studies in patients with hepatic encephalopathy showed that infusion of HepatAmine® reversed the abnormal plasma amino acid pattern characterized by decreased levels of branched chain amino acids and elevated levels of aromatic amino acids and methionine. The trend toward normalization of these amino acids was generally associated with an improvement in mental status and EEG patterns. This clinical response was observed in the majority of patients studied. Nitrogen balance was significantly improved and mortality reduced in these typically protein-intolerant patients who received substantial amounts of protein equivalent as HepatAmine® (8% Amino Acid Injection).

When infused with hypertonic dextrose as a calorie source, supplemented with electrolytes, vitamins, and minerals, HepatAmine® provides total parenteral nutrition in patients with liver disease, with the exception of essential fatty acids.

Phosphate is a major intracellular anion which participates in providing energy for metabolism of substrates and contributes to significant metabolic and enzymatic reactions in all organs and tissues. It exerts a modifying influence on calcium levels, a buffering effect on acid-base equilibrium, and has a primary role in the renal excretion of hydrogen ions.

It is thought that the acetate from lysine acetate and acetic acid, under the conditions of parenteral nutrition, does not impact net acid-base balance when renal and respiratory functions are normal. Clinical evidence seems to support this thinking; however, confirmatory experimental evidence is not available.

The amounts of sodium and chloride present are not of clinical significance.

INDICATIONS AND USAGE

HepatAmine® is indicated for the treatment of hepatic encephalopathy in patients with cirrhosis or hepatitis. HepatAmine® provides nutritional support for patients with these diseases of the liver who require parenteral nutrition and are intolerant of general purpose amino acid injections, which are contraindicated in patients with hepatic coma.

CONTRAINDICATIONS

HepatAmine® is contraindicated in patients with anuria, inborn errors of amino acid metabolism, especially those involving branched chain amino acid metabolism such as Maple Syrup Urine Disease and Isovaleric Acidemia, or hypersensitivity to one or more amino acids present in the solution.

WARNINGS

This product contains sodium bisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

Safe, effective use of parenteral nutrition requires a knowledge of nutrition as well as clinical expertise in recognition and treatment of the complications which can occur. Frequent clinical evaluation and laboratory determinations are necessary for proper monitoring of parenteral nutrition. Studies should include blood sugar, serum proteins, kidney and liver function tests, electrolytes, hemogram, carbon dioxide content, serum osmolarities, blood cultures, and blood ammonia levels.

Administration of amino acids in the presence of impaired renal function or gastrointestinal bleeding may augment an already elevated blood urea nitrogen. Patients with azotemia from any cause should not be infused with amino acids without regard to total nitrogen intake.

Administration of intravenous solutions can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, over-hydration, congested states, or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations of the solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the solutions.

PRECAUTIONS

General

Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation. Significant deviations from normal concentrations may require the use of additional electrolyte supplements.

Strongly hypertonic nutrient solutions should be administered through an indwelling intravenous catheter with the tip located in the superior vena cava.

Special care must be taken when giving hypertonic dextrose to a diabetic or prediabetic patient. To prevent severe hyperglycemia in such patients, insulin may be required.

Peripheral intravenous administration of HepatAmine® (8% Amino Acid Injection) requires appropriate dilution and provision of adequate calories. Care should be taken to assure proper placement of the needle within the lumen of the vein. The venipuncture site should be inspected frequently for signs of infiltration. If venous thrombosis or phlebitis occurs, discontinue infusions or change infusion site and initiate appropriate treatment.

Care should be taken to avoid circulatory overload, particularly in patients with cardiac insufficiency.

In patients with myocardial infarct, infusion of amino acids should always be accompanied by dextrose since in anoxia, free fatty acids cannot be utilized by the myocardium and energy must be produced anaerobically from glycogen or glucose.

Infusion of HepatAmine® may not affect the clinical course of patients with fulminant hepatitis who have a poor prognosis and are generally unresponsive to treatment. It has been shown that the abnormal plasma amino acid pattern in fulminant hepatitis differs from that in chronic liver disease.

Extraordinary electrolyte losses such as may occur during protracted nasogastric suction, vomiting, diarrhea, or gastrointestinal fistula drainage may necessitate additional electrolyte supplementation.

Administration of glucose at a rate exceeding the patient’s utilization rate may lead to hyperglycemia, coma, and death.

Metabolic acidosis can be prevented or readily controlled by adding a portion of the cations in the electrolyte mixture as acetate salts and in the case of hyperchloremic acidosis, by keeping the total chloride content of the infusate to a minimum.

HepatAmine® contains less than 3 mEq chloride per liter.

HepatAmine® contains 10 mmole/liter of phosphate. Some patients, especially those with hypophosphatemia, may require additional phosphate. To prevent hypocalcemia, calcium supplementation should always accompany phosphate administration. To assure adequate intake, serum levels should be monitored frequently.

HepatAmine® has not been adequately studied in pregnant women and pediatric patients; therefore, its safe use in such patients has not been demonstrated.

To minimize the risk of possible incompatibilities arising from mixing this solution with other additives that may be prescribed, the final infusate should be inspected for cloudiness or precipitation immediately after mixing, prior to administration, and periodically during administration.

Use HepatAmine® only if solution is clear, the seal unbroken, and vacuum is present.

Drug product contains no more than 25 mcg/L of aluminum.

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